Saturday, September 01, 2007

(HealthDay News) -- The U.S. Food and Drug Administration has approved Somatuline Depot (lanreotide acetate injection) to treat a rare growth hormone-related disorder called acromegaly, the agency said Friday.

The disorder, caused by an abnormal secretion of the hormone, is characterized by enlarged hands, feet, facial bones, and internal organs such as the heart and liver. If untreated, people with the disorder often die prematurely because of heart and respiratory problems, diabetes, or colon cancer, the FDA said. The disorder affects about 15,000 people in the United States and Canada.

The drug's safety and effectiveness were evaluated in two clinical trials involving 400 people. The most frequent side effects were diarrhea, gallstones, skin reactions, slow heart rate, and changes in blood sugar levels.

Samatuline Depot is marketed by Beaufour Ipsen, based in Paris, France.

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